A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
MenACWY-CRM
Bacterial Infections and Mycoses+3
+ Bacterial Infections
+ Infections
Prevention Study
Summary
Study start date: October 7, 2012
Actual date on which the first participant was enrolled.This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.715 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 10 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations Exclusion Criteria: 1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable or unavailable for the duration of the study period. 3. Previous confirmed or suspected disease caused by N. meningitidis. 4. Previously immunized with a meningococcal vaccine (licensed or investigational). 5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine. (certain exceptions influenza vaccines apply) 7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment. 8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components 10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy, * receipt of immunostimulants, * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives. 11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
Active ComparatorGroup III
PlaceboGroup IV
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 19 locations
GSK Investigational Site
Sacramento, United StatesGSK Investigational Site
Lake Mary, United StatesGSK Investigational Site
Marietta, United States